Prevent opioid overdose deaths by making low price naloxone available to everyone
Naloxone works – CDC reports that tens of thousands of lives have been saved since 1996. Naloxone has been shown to be successful in reversing overdoses in 98.8% of cases.
Greater access saves lives – Both the CDC and local communities report that making naloxone accessible saves lives
To save lives, naloxone needs to be cheap and available OTC
Every day 130 Americans die from an opioid overdose, while naloxone, the antidote that could potentially have reversed these overdoses, sits behind both cost and access barriers. True over-the-counter, low-cost naloxone will be a critical tool to help save lives and begin to stem the loss of life from the opioid crisis.
There are two fundamental barriers to widespread availability of naloxone today – cost and access.
Expense: Naloxone was first approved in 1971 and has been a generic drug since 1985. And yet, multiple companies are price gouging their naloxone products, charging between $110 and $4,500. Despite the on-going opioid crisis, the price of naloxone has gone up 95%-500% in the past few years. Price-gouging of generic naloxone reduces access, costing lives. Moreover, it is bankrupting communities as they struggle to maintain enough naloxone on hand to deal with the increasing death rates from opioid overdoses. This is an epidemic that can’t wait for help and is rapidly getting worse.
Restricted Access: Naloxone’s prescription status and lack of adequate dissemination of information about standing orders has caused pharmacists to act as gatekeepers and discourage greater access. Pharmacists are often uninformed about naloxone and some don’t want to dispense it for worries over treating those dependent on opioids and training hours required.
Harm Reduction Therapeutics is a 501(c)(3) nonprofit company founded to save lives by making naloxone available over-the-counter at the lowest possible cost. Free from profit motive, with investors and partners committed to our life-saving mission, our goal is to launch an FDA-approved product as soon as possible. FDA approval takes time, by design, as the FDA ensures that products are safe and effective for use. Unlike new drugs though, naloxone is already known to be safe and effective, so the studies required for OTC approval are straightforward but will take up to two years to finish and launch – so we need your help now to get started.
The process to FDA approval has been accelerated due to FDA’s desire for naloxone to be available OTC. In 2016, the FDA released a statement saying that they had, for the first time, completed part of the application (the label comprehension studies) for applicants as incentive for someone to bring the product OTC.
Obtain FDA approval for over-the-counter (OTC) naloxone that will be sold at the lowest possible cost to dramatically increase naloxone’s availability.